Mulligan Concept Mobilisation With Movement for Shoulder Dysfunction in Older Adults

December 1, 2023 updated by: Cristina Lirio Romero, University of Alcala

Mulligan Concept Mobilisation With Movement for Shoulder Dysfunction in Older Adults- A Pilot Randomised Clinical Trial

Objective: To pilot the methods proposed for conducting a full randomised clinical trial to evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality in older adults with shoulder dysfunction.

Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes, Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions: Participants will be randomly allocated into control group (n=22) treated with a physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and experimental group (n=22) treated with the same physical therapy standard protocol and Mulligan concept mobilisation with movement. Both interventions will take place three times a week for 2 consecutive weeks.

Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range of motion and pain intensity. Data will be collected at baseline, after each group intervention, and 1 and 3 months after finishing interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shoulder dysfunction is a common problem in older adults reaching up to 21% of prevalence. Shoulder symptoms, such as pain and reduced shoulder active range of motion (AROM) and function, might be associated to chronic pain, disability and decline in physical performance over time. Upper limbs and shoulder joint proper functionality leads to an adequate independence in activities of daily living (ADL) and functional performance. Therefore, maintaining independence in ADL and functional well-being in older adults should be a priority target for health care. A successful therapeutic approach depends on the understanding that the aging process is the responsible of major changes involving muscle disorders and joint stiffness.

Among the most common approaches to treating in¬dividuals with shoulder dysfunction, physiotherapy interven¬tion is often recommended as the first choice for a conservative treatment. Physiotherapy treatment usually includes therapeutic exercises, manual therapy, and various modalities and there are controversies about the most effective approach for pain reduc¬tion, increase in AROM and function, and decrease in disability in people with shoulder dysfunction. There is evidence about the effectiveness of thera¬peutic exercise, and the benefit of manual therapy for improvements in mobility and a trend in improving pain measures, while increases in function and quality of life are still questionable.

Some evidence was found about the effects of therapeutic exercise programs for overall performance improvement in older adults, but not specifically shoulder dysfunction. Regarding manual therapy in elderly, Knebl et al. developed a study about the effectiveness of Spencer manipulative technique in shoulder pain and found an improvement in functionality, shoulder AROM and pain intensity. Van den Dolder et al. investigated the effect of soft tissue massage on shoulder ROM, pain and dysfunction in patients with a mean age of 64 years old and found statistically significant results. Therefore, manual therapy techniques may be an option for correcting joint mechanics, promoting adhesion removal and restoring passive shoulder mobility in older adults.

Mobilisation with movement (MWM) is a manual therapy technique based on the analysis and correction of any minor positional fault in a joint. According to Mulligan, positional faults are due to various soft tissue and/or bone lesions in/around the joint and were explained in patients with shoulder pain by a kinematic study. This technique aims to realign joints positional faults by applying a manually specific oriented glide to a painful joint, assessing and adjusting force intensity, while the patient actively performs joint movement, so that patient's symptoms are immediately relieved and the maneuvers improve pain and movement. Therefore, when a correction mobilization is sustained, pain-free movement is restored and several repetitions are performed in order to get an improvement that lasts over time. The initial effects of MWM were assessed by Teys et al. in adults; who proved its effectiveness in increasing shoulder AROM and decreasing positional faults. Therefore, MWM may be an effective technique in physiotherapy treatment for shoulder dysfunction, as this it addresses passive and active shoulder structures. However, no studies about MWM effectiveness for shoulder dysfunction in older adults have been found.

The purpose of this pilot clinical trial is to pilot the methods proposed to conduct a full randomised controlled clinical trial to determine the effect of Mulligan concept MWM for shoulder dysfunction in older adults. The primary objectives are to evaluate the feasibility of recruitment, randomisation, retention, assessment procedures, and implementation of Mulligan concept MWM intervention. A secondary aim is to undertake a preliminary comparison of patient reported-outcomes and to estimate the variability of these outcomes in older adults with shoulder dysfunction.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Toledo
      • Villarrubia de Santiago, Toledo, Spain, 45360
        • Mensajeros de la Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • to be over 65 years old
  • diagnosed with shoulder dysfunction (shoulder pain and/or limited AROM in the last 4 weeks) by their physician
  • dependent on at least 1 ADL
  • with a limited glenohumeral AROM of 25% - 75%
  • resident in the nursing homes where the study took place.

Exclusion Criteria:

  • subjects with moderate or severe cognitive impairment
  • specific rheumatic diseases, osteoarthritis, neoplasms
  • shoulder joint instability
  • circulatory disorders (hemophilia, clotting problems)
  • skin problems aggravated by contact with the skin
  • traumas in the past month
  • bilateral shoulder disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Experimental Group consist of the physiotherapy standard protocol and active movement plus accessory mobilizations of the humeral head using Mulligan Concept Mobilisation with Movement.
Other: Standard protocol
Control group intervention is the physiotherapy treatment standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction
Other Names:
  • Standard protocol for shoulder pain of Spanish Rheumatology Society
Other: Mulligan Concept Mobilisation with Movement
The internal hand of the physiotherapist stabilises participants´ shoulder girdle and with the thenar eminence of the other hand, performs a posterior-lateral glide of the humeral head. Participants are asked to raise the affected arm in the point of pain onset while the physiotherapist sustains the gliding force to humeral head. The physiotherapist tries to maintain the glide at right angles to the plane of movement throughout the entire range while participants are requested to perform an active elevation. Participants are instructed that the mobilisation procedure, including shoulder movement, had to be pain free
Active Comparator: Control Group
Standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction
Other: Standard protocol
Control group intervention is the physiotherapy treatment standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction
Other Names:
  • Standard protocol for shoulder pain of Spanish Rheumatology Society

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spanish-Shoulder Disability Questionnaire
Time Frame: baseline and 3 times after interventions
SDQ is mostly used in research and clinical practice in several countries and its score can range from minimum [0=no functional limitation] to maximum [100= affirmative to all items], so higher scores mean higher disability
baseline and 3 times after interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion and pain
Time Frame: baseline and 3 times after intervention
glenohumeral range of motion (flexion, abduction, and external and internal rotations) measured with a universal goniometer (E Nonius-F®) and pain intensity measured with 11-point Verbal Numeric Rating Scale (VNS) for its good reliability and validity and usefulness in older adults
baseline and 3 times after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Cristina Lirio Romero, MsC, University of Alcalá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimated)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lirio-001-UAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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